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| Sponsored by: |
Cell Therapeutics |
|---|---|
| Information provided by: | Cell Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00060671 |
Purpose
The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients’ remission, compared to rituximab alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Follicular Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular Lymphoma, Low-Grade |
Drug: rituximab Drug: Pixantrone (BBR 2778) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma (NHL) |
| Estimated Enrollment: | 800 |
This trial is being conducted in patients with indolent (or low-grade) non-Hodgkin’s lymphoma, who have either relapsed or been refractory to previous treatment.
Pixantrone belongs to the DNA intercalator family of chemotherapy agents, which includes anthracyclines. DNA intercalators are commonly used to treat patients with indolent NHL, often in combination with the monoclonal antibody rituximab. This study represents the first large-scale, comparative trial in indolent NHL, designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator, is significantly higher than seen in patients treated with rituximab alone.
This trial is randomized and controlled, which means that participating patients will be randomly assigned to one of two treatment groups:
This trial is expected to recruit around 800 patients in the US, Europe and Israel, with 400 patients recruited to each group.
Patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Show 38 Study Locations More Information
| Study ID Numbers: | AZA III 02 |
| Study First Received: | May 9, 2003 |
| Last Updated: | October 28, 2005 |
| ClinicalTrials.gov Identifier: | NCT00060671 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pixantrone BBR 2778 chemotherapy DNA Intercalator Anthracycline Rituximab Rituxan Mabthera |
monoclonal antibody antibody NHL Non-Hodgkin’s lymphoma indolent low grade Novuspharma |
|
Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Follicular Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Antibodies, Monoclonal Lymphatic Diseases |
Antibodies Lymphoma, Small Cleaved-cell, Follicular Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Lymphoma, Follicular |
Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
